rBCG30 (recombinant Bacillus Calmette-Guérin 30) is a prospective Bacillus Calmette-Guérin vaccine against tuberculosis. It is a live vaccine, consisting of BCG, which has been evaluated as a tuberculosis vaccination. It is genetically modified to produce abundant amounts of mycolyl transferase, a 30kDa antigen (Antigen 85B)^[1] that has been shown to produce a strong immune response in animals^[2][3][4][5] and humans. rBCG30 had been in human clinical trials, ^[6] but no clinical development has been reported since 2007.^[7]

Trials with rBCG30 were halted as the vaccine contained an antibiotic resistance gene.^[8] A new version of the vaccine without the antibiotic resistance marker was created.^[9] This new version of the vaccine, rBCG30-ARMF-II, often called rBCG30, also expresses 2.6 fold more Ag85B than the original vaccine.^[9]

The vaccine completed a Phase I double-blind randomized controlled clinical trial that demonstrated that rBCG30 was safe and immunogenic; during nine months of follow-up, rBCG30, but not BCG, induced significantly increased Antigen 85B-specific immune responses in eight immunological assays (blood lymphocyte proliferation, antibody responses by ELISA, interferon-gamma producing CD4+ and CD8+ T cells ex vivo, central memory CD4+ and CD8+ T cells, interferon-gamma ELISPOT responses, and the capacity of T cells to activate macrophages to inhibit mycobacterial intracellular multiplication).^[6] An additional animal study found that rBCG30 also helps protect against Mycobacterium leprae, the bacteria that causes leprosy.^[10] Disrupting IL10/STAT3 signaling during vaccination through small molecules enhances vaccination efficacy.^{[11][12][13][14]}